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Meet Advena at Medical Fair India in Mumbai

We are pleased to announce that we will be attending Medical Fair India as a visitor. The exhibition will be held on the 13th – 15th March at the Bombay Exhibition Centre in Mumbai. Medical Fair India is India’s no. 1 exhibition and conference for healthcare and with participation from over 20 countries, this fair … Read more

Concept of MDR Medical Device Regulation.

Guidance Document on the Questions & Answers Regarding Clinical Investigation has Been Updated – MDCG 2021-6 Rev.1

The MDCG has updated a guidance document initially published in 2021 regarding Clinical Investigations.  The guidance document is in the form of a Question and Answer and contains a plethora of different questions and answers covering a variety of different scenarios for clinical investigations. The updated document sees the addition of a number of different … Read more

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Meet Advena at Arab Health 2024

We are pleased to announce that we will be exhibiting at next year’s edition of Arab Health. The exhibition will be held between the 29th and 1st of February 2024 in Dubai, United Arab Emirates. At this exhibition, you will get the chance to meet the following members of the Advena Team: If you are interested in … Read more

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Advena at Medica 2023

Earlier this month, Advena participated at the Medica Trade Fair. Medica is considered to be one of the biggest Medical Trade Shows which saw a total of 5,372 companies exhibiting and a further 83,000 visiting in this year’s edition of the trade fair. Medica has given Advena a valuable opportunity to engage with existing clients … Read more

new job vacancies

We Are Recruiting

As Advena Ltd in Malta continues to grow, we are now looking to recruit an experienced Business Administrator to join our team of regulatory specialists on a full-time basis. The successful candidate will work alongside our existing team of regulatory specialists, primarily on the review and preparation of various types of documentation for submission with the Maltese … Read more

Meet Advena at Medica 2023

We are pleased to announce that we will be exhibiting at this years edition of MEDICA. The exhibition will be held on the 13th and 16th of November 2023 in Dusseldorf Germany. If you are interested in one of our services, or you are an existing client who would just like to meet the Advena … Read more

Meet Advena at Med-Tech World 2023

We are pleased to announce that we will be exhibiting at this years edition of Med-Tech World. The exhibition will be held on the 19th and 20th of October 2023 at the Mediterranean Conference Centre in Valletta. If you are interested in one of our services, or you are an existing client who would just … Read more

Advena Services Limited Obtains ISO 13485:2016 Certificate

We are pleased to announce that Advena Services Limited has successfully obtained their ISO 13485:2016 certificate from the Italian Notified Body IMQ, under the scope of MDR/IVDR Article 13 Regulatory Importer Service. Additionally, Advena Limited were also re-certified under ISO 13485:2016 by IMQ, under the scope of European Authorised Representative service, quality management, regulatory affairs … Read more

Notified Body Response Times and Availability

The limited capacity of the Notified Bodies is no secret and is expected to be further affected due to the newly accepted amendment.  This can have a substantial effect on the response times and availability for work of the Notified Bodies, which ultimately means that the manufacturer must wait longer than usual for conformity assessments. … Read more

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